地鼠肾细胞狂犬病纯化疫苗临床研究观察

Observation on clinical trial ofpurified primary hamster kidney cell rabies vaccine(PHKRV)

了解地鼠肾细胞狂犬病纯化疫苗接种安全性及有效性。分别以 1.0ml及 0 .5ml的剂量 ,按暴露后及暴露前免疫程序给 313人接种 ,用小鼠中和试验法检测血清中和抗体效价。结果显示 :临床副反应轻微 ,副反应率为0 .89%～ 15 % ;免疫全量疫苗和半量疫苗的人群均获保护力 ,抗体阳转率为 10 0 % ,免后抗体GMT滴度分别为35 .2IU/ml(n =32 )和 31.4IU/ml(n =37) ,经检验两组无显著性差异 (P>0 .0 5 ) ;免疫全量疫苗和半量疫苗两组的免疫前、后相比 ,经检验有显著性差异 (P <0 .0 5 ) 。

To observe the safety and neutralizing antibody response of the purified rabies vaccine (primary hamster kidney cell) after immunization . During phase Ⅱ clinical trials 313 volunteers were divided into 3 groups :1.0ml×5injections, 0.5ml×5injections and 1.0ml×3injections.The neutralizing antibody of sera was detected by mouse neutralization test.The results showed that the vaccine did not cause any severe and moderate abnormal reactions,the slight reaction rate is 0.89% to 15%.The positive seroconversion rates of neutralizing antibody following post-exposure schedules were 100% (GMT=35.2IU/ml) with 1.0ml/dose and 100%(GMT=30.4IU/ml) with 0.5ml/dose respectively.There is a significant difference between pre- and post- immunization. Therefore the vaccine is safe and effective for human use.